Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA panel recommendation cuts Biorthex workload

This article was originally published in Clinica

Executive Summary

The US FDA's orthopaedic panel meeting's recommendation last December that spinal interbody fusion implants should be down-classified from class III to class II devices is welcome news to Biorthex. As a result of the expected risk regrading, the Montreal, Canada-based spinal technology firm no longer needs to carry out the clinical trials required for the premarket approval application of two of its products, but will be able to seek clearance under the less stringent 510(k) procedure.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT058443

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel